Application 012093
- Type
- NDA
- Sponsor
- BAUSCH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ISORDIL | ISOSORBIDE DINITRATE | TABLET;ORAL | 40MG | Yes | Yes |
| 002 | ISORDIL | ISOSORBIDE DINITRATE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 005 | ISORDIL | ISOSORBIDE DINITRATE | TABLET;ORAL | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 006 | ISORDIL | ISOSORBIDE DINITRATE | TABLET;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 007 | ISORDIL | ISOSORBIDE DINITRATE | TABLET;ORAL | 5MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N012093-001 | ISORDIL | ISOSORBIDE DINITRATE | 40MG | TABLET / ORAL | AB | RLD, RS | 1988-07-29 |
| N012093-002 | ISORDIL | ISOSORBIDE DINITRATE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-07-29 | |
| N012093-005 | ISORDIL | ISOSORBIDE DINITRATE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-07-29 | |
| N012093-006 | ISORDIL | ISOSORBIDE DINITRATE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-07-29 | |
| N012093-007 | ISORDIL | ISOSORBIDE DINITRATE | 5MG | TABLET / ORAL | AB | RLD | 1988-07-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N012093-001 | AB |
| N012093-007 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N012093-001 | ISORDIL | 40MG | TABLET / ORAL | AB | RLD, RS | 1988-07-29 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N012093-002 | ISORDIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-07-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N012093-005 | ISORDIL | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-07-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N012093-006 | ISORDIL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-07-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N012093-007 | ISORDIL | 5MG | TABLET / ORAL | AB | RLD | 1988-07-29 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N012093-001 | ISORDIL | 40MG | TABLET / ORAL | AB | RLD, RS | 1988-07-29 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N012093-002 | ISORDIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-07-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N012093-005 | ISORDIL | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-07-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N012093-006 | ISORDIL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-07-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N012093-007 | ISORDIL | 5MG | TABLET / ORAL | AB | RLD | 1988-07-29 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N012093-001 | ISORDIL | 40MG | TABLET / ORAL | AB | RLD, RS | 1988-07-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N012093-002 | ISORDIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-07-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N012093-005 | ISORDIL | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-07-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N012093-006 | ISORDIL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-07-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N012093-007 | ISORDIL | 5MG | TABLET / ORAL | AB | RLD | 1988-07-29 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012093-001 | ISORDIL | 40MG | TABLET / ORAL | AB | RLD, RS | 1988-07-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012093-002 | ISORDIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-07-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012093-005 | ISORDIL | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-07-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012093-006 | ISORDIL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-07-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012093-007 | ISORDIL | 5MG | TABLET / ORAL | AB | RLD | 1988-07-29 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N012093-001 | ISORDIL | 40MG | TABLET / ORAL | AB | RLD, RS | 1988-07-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N012093-002 | ISORDIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-07-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N012093-005 | ISORDIL | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-07-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N012093-006 | ISORDIL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-07-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N012093-007 | ISORDIL | 5MG | TABLET / ORAL | AB | RLD | 1988-07-29 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012093-001 | ISORDIL | 40MG | TABLET / ORAL | AB | RLD, RS | 1988-07-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012093-002 | ISORDIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-07-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012093-005 | ISORDIL | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-07-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012093-006 | ISORDIL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-07-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012093-007 | ISORDIL | 5MG | TABLET / ORAL | AB | RLD | 1988-07-29 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012093-001 | ISORDIL | 40MG | TABLET / ORAL | AB | RLD, RS | 1988-07-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012093-002 | ISORDIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-07-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012093-005 | ISORDIL | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-07-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012093-006 | ISORDIL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-07-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012093-007 | ISORDIL | 5MG | TABLET / ORAL | AB | RLD | 1988-07-29 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012093-001 | ISORDIL | 40MG | TABLET / ORAL | AB | RLD, RS | 1988-07-29 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012093-002 | ISORDIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-07-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012093-005 | ISORDIL | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-07-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012093-006 | ISORDIL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-07-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012093-007 | ISORDIL | 5MG | TABLET / ORAL | AB | RLD | 1988-07-29 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-03-09 01:35 UTC | 2022-03 | N012093-007 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N012093-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N012093-007 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N012093-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N012093-007 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N012093-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N012093-007 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N012093-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N012093-007 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N012093-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N012093-007 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N012093-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N012093-007 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N012093-007 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N012093-007 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N012093-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N012093-007 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N012093-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | N012093-007 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N012093-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | N012093-007 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N012093-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N012093-007 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N012093-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N012093-007 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N012093-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N012093-007 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N012093-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N012093-007 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N012093-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | N012093-007 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N012093-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | N012093-007 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N012093-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N012093-007 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N012093-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | N012093-007 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N012093-001 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | N012093-007 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N012093-001 | AB | 1 | cb3db0bc1861… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Isosorbide Dinitrate | ISOSORBIDE DINITRATE | Oceanside Pharmaceuticals | 723d9f78-9d77-4575-af27-1aa117e6b8d7 | 2020-03-02 | Warnings, Adverse reactions | 012093 NDA012093 68682-192 68682-193 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0187-0152 | Isordil | isosorbide dinitrate | Valeant Pharmaceuticals North America LLC | NDA | Current |
| 0187-0152 | Isordil | isosorbide dinitrate | Bausch Health Americas, Inc | NDA | Current |
| 0187-0152 | Isordil | isosorbide dinitrate | Bausch Health US LLC | NDA | Current |
| 0187-0152 | Isordil | isosorbide dinitrate | Bausch Health US LLC | NDA | Current |
| 0187-0192 | Isordil | isosorbide dinitrate | Valeant Pharmaceuticals North America LLC | NDA | Current |
| 0187-0192 | Isordil | isosorbide dinitrate | Bausch Health Americas, Inc | NDA | Current |
| 0187-0192 | Isordil | isosorbide dinitrate | Bausch Health US LLC | NDA | Current |
| 0187-0192 | Isordil | isosorbide dinitrate | Bausch Health US LLC | NDA | Current |
| 68682-192 | Isosorbide Dinitrate | isosorbide dinitrate | Oceanside Pharmaceuticals | NDA | Current |
| 68682-193 | Isosorbide Dinitrate | isosorbide dinitrate | Oceanside Pharmaceuticals | NDA | Current |